Overview:

• The QA Technician performs quality assurance duties to prevent or eliminate defects in products for sterile filling operation or in final inspection and packaging operations.
• This individual must work in a detail-oriented, compliant manner in a high stress environment where adherence to deadlines is critical. The individual must display exemplary level of integrity at all times.
• Manage a workload of varying priorities while adhering to strict deadlines.

Duties:

• Monitor the production process and ensure consistency of procedures.
• Perform visual inspection of finished product.
• Perform AQL testing of finished product.
• Review in process documentation.
• Audit manufacturing rooms for adherence to cGMP and SOPs.
• Audit the maintenance of a clean and sanitary environment.
• Review daily/weekly/monthly and bi-monthly logbook entries for completeness.
• Review, approve and issue verified -clean green release stickers to operations.
• Check machine settings.
• Observe/mentor personnel on aseptic performance.
• Perform line clearances and review documentation (circular charts, autoclave tapes etc.) to allow operations to initiate production (release to fill).
• Obtain and maintain gown certification for clean room entry.

Skills:

• All full-time employees are required to work a 40-hour week. At times, additional hours during the weekdays, evenings, and/or weekends will be required to complete tasks and meet deadlines. All applicants must be able to meet the attendance standards.
• Must have a complete knowledge of current Good Manufacturing Practices, United States Pharmacopeia, current Code of Federal Regulations (21 CFR parts 11, 210, 211, 820), and other FDA regulations and guidances.
• Have general math skills: adding, subtracting, multiplication, division, and percentage calculation. Ability to calculate figures and amounts such as discounts, interest, commissions, and proportions.
• Able to use personal computer and standard office equipment such as fax and copy machines, calculators, and printers. Aptitude to learn computer programs as needed (i.e. Microsoft Office Word, Excel) in addition to other business applications.
• Strong verbal and written communication skills. Resourceful and well organized.
• Ability to read and interpret standard documents such as: procedure manuals, employee handbook, and job related publications. Ability to write routine reports and correspondence.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Requirements:

While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk, and hear. The employee is required to use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision for written work and PC use.

• Ability to write, read, and apply technical scientific writing, procedures, and quality policies.
• Ability to work independently in an efficient and detail-oriented manner.
• Ability to work on multiple projects and priorities in a concurrent manner.
• Ability to work in an independent manner, as well as a group environment.
• Ability to apply deductive reasoning and analytical thought to understand complicated issues.
• Ability to receive instructions and follow work rules and company policies.
• Ability to follow safety and security practices.
• Ability to meet deadlines and effectively deal with a high level of office stress.
• Ability to maintain confidentiality of work assignments and personnel issues.

Safety:

Safety glasses, close-toed shoes, and latex gloves are required in many areas within the facility.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year

Schedule:

• 10 hour shift
• 12 hour shift
• 8 hour shift
• Monday to Friday
• Overtime
• Weekends as needed

Work setting:

• In-person
• Manufacturing facility
• Warehouse

Ability to Relocate:

• Decatur, IL 62522: Relocate before starting work (Required)

Work Location: In person